Kornimate/medical-research-clean huggingface dataset:
an observational study of patients' perception of treatment with erythropoiesis-stimulating agents in patients with chronic kidney disease not on dialysis (percepolis)

Conditions: Anemia

Summary: this observational study will evaluate patients' perception of treatment with erythropoiesis-stimulating agents in patients with chronic kidney disease not on dialysis. eligible patients initiated on treatment with mircera (methoxy polyethylene glycol-epoetin beta) will be followed for 6 months.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * patients with chronic kidney disease not on dialysis (with or without previous renal transplantation) * treated or not with esa at time of visit * patients for whom the treating physician had decided to initiate mircera for medical reasons before the commencement of the study * initiation of treatment with mircera at the inclusion visit * accepting and able of completing the esa preference questionnaire exclusion criteria: * participation in a clinical trial on anemia * treatment with mircera during the 3 months before inclusion * dialysis planned in the next 6 months
additional effects of scapular stabilization exercise with exergaming training in stroke patients

Conditions: Stroke

Summary: the world health organization has termed stroke to be a clinical syndrome, of presumed vascular origin, typified by rapidly developing signs of focal or global disturbance of cerebral functions and the leading cause of death worldwide in 2016 making it a major non-contagious cause of death. this study would be beneficial in a way that it will give a valuable input and will contribute for the knowledge of interventions for stroke with an emphasis on upper extremity function among health care practitioners for their goal of promoting health, prevention of diseases and improving quality of life.

exergaming can contribute to improvement of the function of ue motor and arom in chronic stroke patients, additional studies with a large number of subjects with long follow-up periods are required to determine their effectiveness neurorehabilitation stimulation . the exergaming protocol presented in this study represents success a tool for ue functional aspects in patients with chronic stroke. it has shown improvement in gripping strength, handicrafts and ue's operational recovery. movement control and the position of scapula determine an optimal upper limb function. paresis leading to scapular disorientation ultimately exaggerates motor impairment in upper extremities. recent literature has emphasized on the need to design an upper extremity protocol including scapular stabilization exercises in order to increase muscular strength and decrease scapular dyskinesis .the results of a study showed that scapular stability exercises had an impact on hand function and the ability to move hemiplegic patients after stroke.

Eligibility criteria:
inclusion criteria: * chronic stroke patients with an initial onset of 6 months or above. * those who had 30-65 points by fugl-meyer assessment of upper extremity * those who had minimum score 24 on mini mental state examination * those who have the ability to execute at least 20' of active shoulder flexion and abduction against gravity those who could understand and follow instructions provided by the investigator * those who are medically stable enough to participate in active rehab * those who have no problems with auditory or visual functioning. * modified ashworth scale (mas) 1-3 exclusion criteria: * orthopaedic or mental health problems * those who have difficulty to stay in a sitting position * severe conditions such as uncontrolled blood pressure or angina * history of epilepsy * the refusal to play a video game.
comparison of dexamethasone doses on persistent postmastectomy pain

Conditions: Mastectomy, Modified Radical

Summary: this study evaluates the effect of dexamethasone on persistent surgical pain after mastectomy operations. half of the participants will receive 0.1 mg/kg dexamethasone and the other half will receive 0.2 mg/kg dexamethasone.

breast cancer is the most frequent malignancy of middle age women (%32) and causes 19% of cancer-related deaths. acute pain can contribute to the development of persistent surgical pain. persistent postsurgical pain has been demonstrated to be clinically relevant in 10% to 50% of patients undergoing various common operations, including breast cancer surgery. the pathogenic mechanisms are multiple, including nerve damage related to surgical technique resulting in risk of intercostobrachial neuralgia, neuroma pain, or phantom breast pain. multimodal analgesic strategies are important.glucocorticoid steroids can also provide beneficial effects when administered in appropriate doses as part of a multimodal analgesic regimen in the perioperative setting. a recent study demonstrated that preoperative application of dexamethasone reduced postoperative nausea and vomiting and pain in patients after thyroidectomy.. it is possible that the already established reduction in prostaglandin synthesis mediated by dexamethasone contributes to the analgesia. and also there are a lot of mechanisms more.

Eligibility criteria:
inclusion criteria: * 18-70 years old, female patients * written informed consent. exclusion criteria: * american society of anesthesiologists physical status ˂3 * any contraindication to dexamethasone * emergency or urgent procedure * obesity body mass index ≥27 kg m2 * motion sickness and vertigo patients * axis i psychiatric disease (major depressive disorder, bipolar disorder, schizophrenia, etc.) * significant hepatic (alanine aminotransferase or aspartate aminotrans \> 2 times normal) * renal (serum creatinine \> 2 mg/dl) impairment

Keywords: dexamethasone mastectomy persistent surgical pain
postmarketing surveillance of the safety and effectiveness of daclatasvir and asunaprevir for the treatment of chronic hcv genotype 1b infection in the routine clinical practice in korea

Conditions: Hepatitis C

Summary: the primary objective of this study is to describe the safety of the combination of daklinza (daclatasvir) and sunvepra (asunaprevir) when used for the treatment of chronic hepatitis c (chc) genotype 1b patients in real-life conditions when used according to its registered indications.


Eligibility criteria:
inclusion criteria: * patients with chc genotype 1b and compensated liver disease, including cirrhotic patients * eligible for treatment with daklinza and sunvepra as indicated in the locally approved prescribing information. exclusion criteria: * off-label use of daklinza and sunvepra * patients with a contraindication for the use of daklinza and sunvepra as described in the locally approved prescribing information
a post marketing surveillance (pms) study of liraglutide in subjects with type 2 diabetes mellitus in india

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this study is conducted in asia. the aim of this study is to evaluate the safety and effectiveness of liraglutide in subjects with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * subjects with type 2 diabetes, including newly-diagnosed patients / those already receiving other anti-diabetic medications including glp-1 analogues, who require treatment with liraglutide according to the clinical judgment of their treating physician * subjects who are capable of giving study-specific signed informed consent before any collection of information exclusion criteria: * subjects with type 1 diabetes * subjects who are or have previously been on liraglutide * subjects who have previously been enrolled in the study * subjects who are participating in another clinical trial * subjects with a hypersensitivity to liraglutide or to any of the excipients (disodium phosphate dihydrate, propylene glycol, phenol, water for injections) * subjects who are pregnant, breast feeding or have the intention of becoming pregnant within the following 6 months
hyaluronidase in intra-articular steroid injection treating the adhesive capsulitis for shoulder

Conditions: Adhesive Capsulitis of Shoulder

Summary: adhesive capsulitis (ac) is painful and disabling condition that is associated with a gradual loss of shoulder motion. intra-articular steroid injection is a common treatment in the initial painful stage of ac, and its use in combination with hyaluronidase may offer increased therapeutic efficacy owing to synergistic effects. we determined the therapeutic efficiency of the co-administration of hyaluronidase in early ac by evaluating symptomatic, anthropometric, and imaging changes.

we enrolled eligible patients with primary adhesive capsulitis in the initial stage.the subjects were randomly assigned into 3 groups to receive ultrasound-guided intra-articular injections with 20 mg (group a) and 40 mg triamcinolone acetonide (group b) and 20 mg acetonide combined with hyaluronidase (group c). the outcome measures included the visual analogue scale (vas), the shoulder disability questionnaire (sdq), abduction and external rotation range of motion, and intra-sheath fluid (isf) before treatment and at 2, 4, 8, and 16 weeks after treatment.

Eligibility criteria:
inclusion criteria: * normal findings on simple x-rays of the shoulder but limitations in passive range of motion on physical examination * increased intra-sheath fluid (isf) sufficient to encircle the long head of the biceps tendon within the upper portion of the bicipital groove of the humerus. exclusion criteria: * ultrasonographic diagnosis of other concomitant fundamental abnormalities causing shoulder pain such as rotator cuff tear, bicipital tendon rupture, calcific tendinopathy, and subacromial-subdeltoid bursitis * a history of shoulder injury * a history of more than 1 year of conservative treatment for chronic shoulder pain * corticosteroid or hyaluronidase injections within the prior 6 months * hemiplegic shoulder * self-reported history consistent with scapula fracture or disarticulation * ipsilaterally cervical herniated intervertebral disc or brachial plexus injury * diabetes mellitus refractory to insulin therapy or glycated hemoglobin greater than 6.5 * refusal to participate in this study

Keywords: intra-articular injections steroids hyaluronidase ultrasonography
reserpine for the treatment of cocaine dependence - 1

Conditions: Cocaine-Related Disorders; Substance-Related Disorders

Summary: the purpose of this study is to assess the efficacy and safety of reserpine for the treatment of cocaine dependence.

to assess the efficacy and safety of reserpine in reducing cocaine use in subjects with cocaine dependence. this is a double-blind, placebo-controlled, parallel-group design with a 2 week baseline period.

Eligibility criteria:
inclusion criteria: be at least 18 yrs of age; dsm-4 diagnosis of cocaine dependence; treatment seeking individuals; have the ability to understand and provide written informed consent; females of child bearing potential using appropriate birth control method exclusion criteria: additional criteria available during screening at the site.

Keywords: cocaine dependence
soft drinks and osteoporosis in whi participants

Conditions: Osteoporosis; Diet Habit

Summary: osteoporotic fractures, as a consequence of a reduced mineral bone density (bmd) represents a major public health problem. the lifetime risk of fractures exceeds 40% for women and 13% for men. at least ten different individual characteristics have already been proposed, evaluated, and some of them accepted as risk factors. some of those risk factors were compiled in a tool developed by the world health organization in order to predict the ten-risk for a new fracture, even without considering bmd in that prediction . increased consumption of carbonated soft drinks has been reported to have associations to a lower bone mineral density and an increment in bone fractures among young and also elder subjects. however, some prospective studies have not found any significant associations and others suggested that risk is only increased for some kinds of beverages, like cola beverages, but not to the entire universe of soft drinks. in this sense, a large prospective analysis performed on 1413 women and 1125 men from the framingham offspring cohort, analyzed- the relation between soft drinks consumption and bmd at the spine and 3 hip sites. cola intake was associated with significantly lower bmd at each hip site, but not the spine, in women but not in men. similar results were observed for diet cola and, although weaker, for decaffeinated cola. no significant relations between non-cola carbonated beverage consumption and bmd were observed. in spite of the fact that reduced bone mineral density and osteoporotic fractures represent an increasing burden of disease and disability in postmenopausal women, most of the studies performed in this population used bmd as primary outcome, and not common osteoporotic fractures (e.g. hip, spine or wrist). therefore, there is no conclusive evidence of a potential causal association between soft drinks (cola and non-cola) and fractures in a population in which osteoporotic fractures hold the highest incidence. this research proposal is based on using the women health initiative data to analyze the relation between cola and non-cola soft drinks consumption on common osteoporotic fractures. bmd will be considered a secondary outcome.


Eligibility criteria:
inclusion criteria: * postmenopausal women * more than one day of follow up * dietary information on soft drinks exclusion criteria: previous hip fracture

Keywords: osteoporosis hip fractures soft drinks
training intensity after coronary bypass grafting

Conditions: Coronary Artery Bypass

Summary: the purpose of this study is to investigate the effect of high and moderate intensity exercise training after coronary bypass surgery. the subjects are randomised to training at either 60-70% or 85-95% of their maximal capacity daily for four weeks. primary outcome measure is change in maximal aerobic capacity, measured as change in maximal oxygen consumption, after the training period. secondary outcome measures are change in quality of life, heart rate variability, ultrasound measures of the heart and blood variables, including endothelian markers.

the exercise part of cardiac rehabilitation today is often composed of low to moderate intensity training. several studies have found interval training with high intensity to be more effective in improving physical capacity in healthy subjects and also in different patient populations. we therefore wish to compare high intensity interval training with moderate intensity training in patients operated with coronary bypass surgery. maximal oxygen consumption is shown to be the best indicator of how many years you life, both in healthy persons and in cardiac patients. the subjects in this study is attending a four week rehabilitation program at an residential institution in norway. they are randomised to do either a moderate or a high intensity aerobic training session each day. the hypothesis in advance, was that high intensity interval training lead to a greater improvement in maximal oxygen consumption than training with moderate intensity. we also hypothesised that there would be no difference between the two groups after 6 months, since then the patients had to administer their own exercise training.

Eligibility criteria:
inclusion criteria: * coronary artery grafting (4-12 weeks ago) exclusion criteria: * not able to exercise on a treadmill * left ventricle ejection fraction \< 30% * hemodynamic significant valve deficit (\> nyha classification ii)

Keywords: coronary artery bypass (e04.928.220.520.220) exercise test [e01.370.370.380.250] echocardiography [e01.370.370.380.220] quality of life [k01.752.400.750]
copd rehabilitation in primary and secondary health care

Conditions: Chronic Obstructive Pulmonary Disease

Summary: pulmonary rehabilitation of copd patients are implemented in a non-randomized manner in two settings: primary and secondary health care. the effect on quality of life and hospitalizations will be evaluated


Eligibility criteria:
inclusion criteria: * copd patients exclusion criteria: * severe concomitant chronic disease

Keywords: copd rehabilitation health services research
qtc study of rosi xr in healthy volunteers

Conditions: Alzheimer's Disease

Summary: this study is a randomised double blind, parallel group, and will evaluate the effects of repeat oral doses of rsg- xr for 21 days on the qtc interval compared to placebo in a population of healthy adult males and females.

an extended release (xr) formulation of rosiglitazone maleate (rsg), a new formulation of rosiglitazone, is being investigated as a treatment for patients with mild to moderate alzheimer's disease (ad). this study is a randomised double blind, parallel group, and will evaluate the effects of repeat oral doses of rsg- xr for 21 days (due to the long half-life of the main metabolite m10) on the qtc interval compared to placebo in a population of healthy adult males and females between 18 and 45 years of age. moxifloxacin, a drug with well-quantified qtc prolongation, will be included as a positive control in order to validate the ability of the study to detect small changes in qtc.

Eligibility criteria:
inclusion criteria: * healthy male and female volunteers aged between 18 and 45 * female of non child bearing potential or if of child bearing potential they must use adequate contraception for the duration of the study up until 14 days after the last dose * body weight greater than or equal to 45 kg and bmi within the range 19 - 32 inclusive * subjects must provide full written informed consent exclusion criteria: * cardiac conduction abnormalities * any history of myocardial infarction, syncope, or cardiac arrhythmias or a history of uncontrolled hypertension or unstable heart disease * subjects with a systolic blood pressure outside the range of 90 to 150 mmhg or diastolic blood pressure outside the range of 50 to 100 mmhg * subjects with a personal or family history of qtc prolongation or unexplained cardiac arrest. * has a history of illicit drug use or alcohol abuse within the past year or a positive pre-study test for alcohol, cotinine, or drugs of abuse at screening or prior to the start of dosing * alanine aminotransferase (alt), aspartate aminotransferase (ast), or alkaline phosphatase values greater than 2.5 times the uln, total bilirubin values \>1.5 times the upper limit of normal (uln), or history of severe hepatobiliary disease (e.g. hepatitis b or c, or cirrhosis, child-pugh class b/c) * a positive test at screening for hepatitis b, hepatitis c, or human immunodeficiency virus (hiv) * use of any agents that are known to inhibit or induce cytochrome cyp3a4 enzymes within 7 days prior to the first dose of study drug (including foods or supplements such as grapefruit-containing products, mustard greens, kale, kohlrabi, broccoli, collard greens, brussel sprouts, watercress, charbroiled meats or st. john's wort * use of any prescription or non-prescription drugs, in particular drugs known to inhibit or induce cyp2c8, vitamins (exceptions may be considered on a case-by-case basis with the gsk medical monitor), herbal and dietary supplements within fourteen days prior to the first dose of study drug * lactating or pregnant females

Keywords: qtc pharmacokinetics rosiglitazone xr cardiac conduction healthy volunteers
phase i randomized study of adeno-associated virus-cftr vector in patients with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: objectives: i. determine the maximum tolerated dose of recombinant adeno-associated virus-cftr vector in patients with cystic fibrosis. ii. assess the safety of this gene therapy in these patients. iii. assess the in vivo gene transfer of this vector in these patients. iv. assess the cftr gene expression and physiologic activity following gene transfer in these patients. v. assess the clinical impact of cftr gene expression following gene transfer in these patients. vi. monitor patient immune response directed against cftr or vector components following vector administration.

protocol outline: this is a randomized, dose escalation, double blind, placebo controlled, multicenter study. patients are randomized to receive either adeno-associated virus-cftr (aav-cftr) vector or placebo. patients undergo tests on days -10 to -4 to rule out adenovirus and adeno-associated virus infections. patients then receive aav-cftr vector intranasally to the right or left inferior turbinates and placebo to the other side of the nose. the next day, patients receive an endobronchial dose of aav-cftr vector to the superior segment of the right lower lobe. cohorts of 2-4 patients each receive escalating doses of aav-cftr vector until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose level immediately preceding the dose at which at least 2 subjects develop dose limiting toxicity. patients are followed at day 10, then at 1, 2, 3, 6, 9, and 12 months.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- diagnosis of cystic fibrosis (cf) with mild to moderate lung disease; fvc at least 60% predicted; schwachman-kulczycki score at least 65; sweat chloride greater than 60 meq/l all cf genotypes allowed no sputum colonization with burkholderia cepacia or another multiply resistant organism no recurrent or intermittent hemoptysis; at least 1 year since significant hemoptysis requiring transfusion or embolization or coughing of greater than 30 ml of blood more often than once a week --prior/concurrent therapy-- at least 30 days since hospitalization or home intravenous antibiotic therapy for pulmonary exacerbation no concurrent investigational drugs or therapy --patient characteristics-- other: no concurrent cigarette smoking; not pregnant or nursing; negative pregnancy test; fertile patients must use effective contraception

Keywords: cardiovascular and respiratory diseases cystic fibrosis genetic diseases and dysmorphic syndromes rare disease
prediction of hypotension using perfusion index following spinal anesthesia in lower segment caesarean section

Conditions: Spinal; Hypotension; Perfusion Index

Summary: spinal anesthesia for caesarean section is invariably associated with variable degree of hypotension. hypotension that occurs may be detrimental to various organ system due to inadequate perfusion. various methods and agents have been tried in order to address this problem. however, this calamity is far from over. perfusion index is one such attempt to address the problem of hypotension by predicting which group of parturient may develop hypotension. this is a type of non-invasive method of assessing the relative vascular tone with the use of pulse oximeter which calculates the ration of pulsatile versus the non-pulsatile component of the blood flow. during normal physiological changes in pregnancy, there is relative loss of vascular tone which predisposes this group of patient to sudden development of hypotension after the sympathetic block due to spinal anesthesia. thus, the aim of the study is to use the non-invasive perfusion index data to predict the occurrence of hypotension in a parturient so that helps us to guide fluid and other drug therapy to address the problem of hypotension.


Eligibility criteria:
inclusion criteria: 1. asa ii physical status. 2. planned for elective lscs 3. gestational age \>36 weeks and \<41 weeks exclusion criteria: 1. patient's refusal. 2. emergency lscs. 3. patient's with contraindications to spinal anesthesia 4. patient with bmi \>40, preeclampsia, placenta praevia. 5. patients with comorbidities like cerebrovascular or cardiovascular disease, and gestational diabetes.

Keywords: spinal hypotension perfusion index caesarean section